Genetic Testing Medicare Genetic Testing Regulatory Considerations Regulations

Genetic Testing: Medicare Genetic Testing: Regulatory Considerations Regulations and Policy Considerations Sharon Zehe, JD Vice President, Business Affairs, Mayo Medical Laboratories Legal Counsel, Mayo Clinic Andrew B. Wachler, Esq. Wachler & Associates, P. C. 210 E. 3 rd Street, Suite 204 Royal Oak, MI 48067 awachler@wachler. com 248 -544 -0888 G 2 Intelligence Lab Institute 2017 Washington, D. C. October 26, 2017 © 2017 MFMER | slide-

Topics to Cover • Privacy • Discrimination • Standard of Care in Laboratory Testing • Variants of Unknown Significance © 2017 MFMER | slide-2

Privacy • Is genetic sequence protected health information? • Sequence versus interpretation of sequence • Fingerprint versus sequence • Delicate balance between sharing sequencing data and related data, while protecting identity of participants / patients • Environmental Clinical History • Family History Treatment plans © 2017 MFMER | slide-3

Privacy in Research • How can data be used and shared before consent required? • Direct-to-Consumer labs • Referral laboratories • Many states have enacted “opt in” research provisions relating to genetic research • Definition of “genetic research” varies • Not all include use of biospecimens © 2017 MFMER | slide-4

Informed Consent • Consent for research versus waived consent • OHRP Requirements • Common Rule proposal regarding biospecimen use • Did not implement informed consent for use of biospecimens • Bearder lawsuit in Minnesota • Resulted in destruction of a million newborn blood spots used for research • State law now requires consent for storage © 2017 MFMER | slide-5

Discrimination • Genetic Information Nondiscrimination Act • Became law in 2008 • Goal is to protect individuals from discrimination based on genetic information • Health Insurance • Employment © 2017 MFMER | slide-6

Discrimination • Employment • Pre and post employment testing prohibited • Prohibits discrimination in health insurance • Does not cover life insurance, disability insurance, or long-term care insurance • Patients worried about results for these purposes © 2017 MFMER | slide-7

Variants of Unknown Significance • Williams v. Quest / Athena (South Carolina): • In 2007, Athena reported variant of unknown significance on 2 year old patient • Child had a missense mutation SCN 1 A, which at the time was not clearly linked to Dravet Syndrome • Mother claims Athena should have known a defect in SCN 1 A was not of unknown significance • Suspected, but not fully validated • Case could impact the standard of care for genetic testing © 2017 MFMER | slide-8

Potential Impacts • How do providers balance negligence standards against regulatory validation requirements? • Suspicion of connection? • CLIA standard? • FDA standard? • What is provider’s obligation to provide updates when VUS becomes known? • Based on what was known at the time? • Or will future standard of care require a look back? • If so, how far back? © 2017 MFMER | slide-9

Issues in Reimbursement 10 • Is the Genetic Test: • A Covered Service? • Medically Necessary and Reasonable? • Documented? • Physician Order / Requisition • Physician Attestation • Supporting Medical Records • Covered by an LCD? • Indicated? • Subject to the Mol. DX Program? • Assigned a CPT Code(s)? • Other Payer Requirements? © 2017 MFMER | slide-10

Covered Service - Diagnostic Tests 11 • Medicare Part B will cover “medical and other health services” which includes “diagnostic services” and “diagnostic laboratory tests. ” Social Security Act §§ 1832(a)(2)(B), 1861(s)(2)-(3). © 2017 MFMER | slide-11

Covered Service - Diagnostic Tests 12 • Excluded from coverage are services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. Social Security Act § 1862(a)(1)(A); 42 CFR § 411. 15(k)(1). © 2017 MFMER | slide-12

Covered Service - Diagnostic Tests 13 • 42 CFR § 410. 32 • (a) - All diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests must be ordered by the physician who is treating the beneficiary, that is, the physician who furnishes a consultation or treats a beneficiary for a specific medical problem and who uses the results in the management of the beneficiary’s specific medical problem. Tests not ordered by the physician who is treating the beneficiary are not reasonable and necessary. • (b)(1) - Basic rule. Except as indicated in paragraph (b)(2) of this section, all diagnostic x-ray and other diagnostic tests covered under section 1861(s)(3) of the Act and payable under the physician fee schedule must be furnished under the appropriate level of supervision by a physician as defined in section 1861(r) of the Act. Services furnished without the required level of supervision are not reasonable and necessary (see § 411. 15(k)(1) of this chapter). © 2017 MFMER | slide-13

Shared Burden to Provide Documentation? 14 • The burden rests with the “provider, supplier, or beneficiary, as appropriate, [to] furnish to the [contractor] sufficient information to determine whether payment is due and the amount of payment. ” 42 CFR § 424. 5(a)(6); see also Social Security Act § 1833(e). • Our initial request for information is made to the entity submitting the claim. That entity should submit whatever documentation it has in support of the claim. If the documentation provided by the entity submitting the claim does not demonstrate that the service is reasonable and necessary, we will take the following action: (1) Provide the ordering physician information sufficient to identify the claim being reviewed; (2) request from the ordering physician those part of a beneficiary’s medical record that are relevant to the specific claim(s) being reviewed; and (3) if the ordering physician does not supply the documentation requested, inform the entity submitting the claim(s) that the documentation has not been supplied and deny the claim. • Source: Medicare Program; Coverage and Administrative Policies for Clinical Diagnostic Laboratory Services, Final Rule, 66 Fed. Reg. 58788, 58800 (Nov. 23, 2001) © 2017 MFMER | slide-14

Medical Necessity 15 • Medicare Program Integrity Manual – Chapter 13 • Section 13. 3 – Individual Claim Determinations • When making individual claim determinations, the contractor shall determine whether the item or service in question is covered by based on an LCD or the clinical judgment of the medical reviewer. • An item or service may be covered by a contractor if it meets all of the conditions listed § 13. 5. 1, Reasonable and Necessary Provisions in LCDs • Section 13. 5. 1 – Reasonable and Necessary Provisions in LCDs • An item or service may be covered by a contractor LCD if: • It is reasonable and necessary under 1862(a)(1)(A) of The Act. Only reasonable and necessary provisions are considered part of the LCD. © 2017 MFMER | slide-15

Medical Necessity 16 • Medicare Program Integrity Manual – Chapter 13 • Section 13. 5. 1 – Reasonable and Necessary Provisions in LCDs • Reasonable and Necessary • Contractors shall describe in the draft LCD the circumstances under which the item or service is reasonable and necessary under 1862(a)(1)(A). Contractors shall consider a service to be reasonable and necessary if the contractor determines that the service is: • Safe and Effective • Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000 which meet the requirements of the Clinical Trials NCD are considered reasonable and necessary); and • Appropriate, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it is: • Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient's condition or to improve the function of a malformed body member; • Furnished in a setting appropriate to the patient's medical needs and condition; • Ordered and furnished by qualified personnel; • One that meets, but does not exceed, the patient's medical need; and • At least as beneficial as an existing and available medically appropriate alternative. © 2017 MFMER | slide-16

Medical Necessity 17 • Medicare Program Integrity Manual – Chapter 13 • Section 13. 7. 1 – Evidence Supporting LCDs • Contractor LCDs shall be based on the strongest evidence available. The extent and quality of supporting evidence is key to defending challenges to LCDs. The initial action in gathering evidence to support LCDs shall always be a search of published scientific literature for any available evidence pertaining to the item or service in question. In order of preference, LCDs should be based on: • Published authoritative evidence derived from definitive randomized clinical trials or other definitive studies, and • General acceptance by the medical community (standard of practice), as supported by sound medical evidence based on: • Scientific data or research studies published in peer-reviewed medical journals; • Consensus of expert medical opinion (i. e. , recognized authorities in the field); or • Medical opinion derived from consultations with medical associations or other health care experts; • Acceptance by individual health care providers, or even a limited group of health care providers, normally does not indicate general acceptance by the medical community. Testimonials indicating such limited acceptance, and limited case studies distributed by sponsors with financial interest in the outcome, are not sufficient evidence of general acceptance by the medical community. The broad range of available evidence must be considered and its quality shall be evaluated before a conclusion is reached. • LCDs which challenge the standard of practice in a community and specify that an item or service is never reasonable and necessary shall be based on sufficient evidence to convincingly refute evidence presented in support of coverage. • Less stringent evidence is needed when allowing for individual consideration. © 2017 MFMER | slide-17

Palmetto GBA - Mol. DX 18 • Molecular Diagnostic Services Program – Mol. DX • The purpose of the Mol. DX program is to identify tests, determine coverage, and determine reimbursement. • Mol. Dx recognizes that molecular diagnostic tests “present challenges because the Clinical Laboratory Fee Schedule pricing methodology does not account for the unique characteristics of these test. ” • To establish consistency in coverage and pricing decisions for molecular diagnostic tests, laboratories must bill with the correct CPT/HCPCS code and must also apply for and obtain a unique test identifier prior to billing for most molecular diagnostic tests. • Currently implemented in 6 Medicare jurisdictions • JE A/B MAC (California, Nevada, Hawaii and the US Pacific Territories of Guam, American Samoa and the Northern Marianas) administered by Noridian Healthcare Solutions • JF A/B MAC (Oregon, Washington, Idaho, Utah, Montana, Wyoming, Nevada, Arizona, North Dakota, South Dakota, Alaska, and the Aleutian Islands) administered by Noridian Healthcare Solutions • JM A/B MAC (North Carolina, South Carolina, Virginia, and West Virginia) administered by Palmetto GBA • J 5 A/B MAC (Iowa, Kansas, Missouri, and Nebraska) administered by WPS Government Health Administrators • J 8 A/B MAC (Michigan and Indiana) administered by WPS Government Health Administrators • J 15 A/B MAC (Ohio and Kentucky) administered by CGS Administrators, LLC © 2017 MFMER | slide-18

Local Coverage Determinations 19 • Example: Local Coverage Determination (LCD): Mol. DX: BRCA 1 and BRCA 2 Genetic Testing (L 36161) • Original Effective Date: 4/15/2016 • Important Considerations: • Coverage Indications • Limitations on Coverage • Coding Information • CPT/HCPCS Codes • ICD-9/ICD-10 Codes that Support Medical Necessity • Documentation Requirements © 2017 MFMER | slide-19

Medicare Audit Contractors • Medicare Administrative Contractors (MACs) • Zone Program Integrity Contractors (ZPICs) • Uniform Program Integrity Contractors (UPICs) • Recovery Audit Contractors (RACs) • Medicare RACs & Medicaid RACs • Supplemental Medical Review Contractor (SMRC) • Office of Inspector General (OIG) audits © 2017 MFMER | slide-20

Medicare Appeals Process • Rebuttal and Discussion Period • Redetermination • Appeal deadline: 120 days (30 days to avoid recoupment) • Reconsideration • Appeal deadline: 180 days (60 days to avoid recoupment) • Full and early presentation of evidence requirement • Administrative Law Judge Hearing • Appeal deadline: 60 days • CMS will recoup any alleged overpayment during this and following stages of appeal • Medicare Appeals Council (MAC) • Appeal deadline: 60 days • Federal District Court • Appeal deadline: 60 days © 2017 MFMER | slide-21

CMS Final Rule: New Regulations to Address Backlog Major changes in the Final Rule include: 1) Precedential authority to selected Medicare Appeals Council decisions 2) Attorney Adjudicators at OMHA 3) Submission of Evidence for Medicare appeals 4) Appointed Representatives 5) CMS Contractors participation in ALJ proceedings © 2017 MFMER | slide-22

Settlement Conference Facilitation (SCF) • Designed to bring CMS and Appellant together to discuss the potential of a mutually agreeable resolution for claims appealed to the ALJ • If a settlement cannot be reached, claims return to ALJ appeal level • SCF Expansion • Phase I (Implemented June 2014) – Limited Part B claim eligibility • Phase II (October 2015) – Expanded Part B claims eligibility requirements • Phase III (February 2016) – Part A claims eligible © 2017 MFMER | slide-23

Statistical Sampling Initiative • Provides appellants an additional avenue to handle large volumes of claims appealed to the ALJ appeal level. • Statistical sampling draws a random sample from a universe of claims and extrapolates (projects) the results of the sample to the entire universe of claims • OMHA statistical sampling is conducted using a trained and experienced statistical expert to develop the appropriate sampling methodology in accordance with Medicare guidance (CMS, Medicare Program Integrity Manual (Pub. 10008), ch. 8) and randomly select the sample units • ALJ then review the sample units and make findings and a decision on those sample units © 2017 MFMER | slide-24

QUESTIONS? 25 Sharon Zehe, JD Vice President, Business Affairs, Mayo Medical Laboratories Legal Counsel, Mayo Clinic Andrew B. Wachler, Esq. awachler@wachler. com 248 -544 -0888 © 2017 MFMER | slide-25